The following data is part of a premarket notification filed by Shaw Sun Systems with the FDA for Shaw Sun Systems Model 2400.
| Device ID | K885184 |
| 510k Number | K885184 |
| Device Name: | SHAW SUN SYSTEMS MODEL 2400 |
| Classification | Light, Ultraviolet, Dermatological |
| Applicant | SHAW SUN SYSTEMS RT. 2 BOX 216 Brookline, MO 65619 |
| Contact | Rocky L Hilburn |
| Correspondent | Rocky L Hilburn SHAW SUN SYSTEMS RT. 2 BOX 216 Brookline, MO 65619 |
| Product Code | FTC |
| CFR Regulation Number | 878.4630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-13 |
| Decision Date | 1989-01-09 |